How to obtain the Business Operating Authorization?

How to obtain the Business Operating Authorization?

To keep your company regularized within the rules in force with the National Health Surveillance Agency (ANVISA), we cannot forget the importance of the Operating Authorization (AFE). The start of operation of your company without this license is a health violation and may result in a warning, interdiction, cancellation of authorization and license and/or fine.

In this blog we will deal with obtaining the Company Operating Permit, if you have any questions, talk to our consultants.

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What you will see in this blog:

  • How to apply for the AFE?
  • What is the deadline for analyzing AFE's petitions?
  • From what moment is the company authorized to operate?
  • Claim your AFE!

How to apply for AFE?

The request for an Operating Permit is made electronically on the ANVISA website. At that moment, it is necessary to register the company on the website, prove the size of the company, gather the necessary documentation and pay the registration fee.

The next step will be to send the paperwork to Brasilia and follow the process with ANVISA.

It is very important that the sanitary license includes all the activities that will be carried out, as the company will receive AFE for the activities included in the license that is issued by the municipal or state body.

What is the deadline for analyzing AFE petitions?

In cases involving AFE requests, the petitions are analyzed by ANVISA within 30 days and this period may vary.

In situations where the agency understands that the establishment does not comply in any way with what is specified in the health regulation, the AFE is canceled, with the need to adapt and restart the request process.

When does your Company Operating Permit become valid?

Your Company Operating Permit takes effect from the moment of publication in the Federal Official Gazette (DOU). From that moment your company can act within its activity.

Apply for your Company Operating Permit with Stone Okamont!

Our company has the expertise to start your regulatory process and an experienced team. The best way to apply for your Company Operating Permit is with Stone Okamont.

Want to know the ideal path

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